The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

  • STATUS
    Recruiting
  • participants needed
    160
  • sponsor
    Changchun BCHT Biotechnology Co.
Updated on 28 May 2022

Summary

Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).

Description

Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1.

All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation.

All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.

Details
Condition Influenza Prevention
Treatment Live Attenuated Influenza Vaccine, Live Attenuated Influenza Vaccine, Live Attenuated Influenza Vaccine placebo
Clinical Study IdentifierNCT05056519
SponsorChangchun BCHT Biotechnology Co.
Last Modified on28 May 2022

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